Fastener applicator with interlock

ABSTRACT

The present disclosure relates to a fastener applicator including a handle, a first trigger coupled rotatably with respect to the handle, and a second trigger coupled rotatably with respect to the handle. An interlock is disposed with the second trigger and comprises a cam follower engaged in a cam channel that selectively prevents rotation of the second trigger relative to the first trigger depending on a location of the cam follower within the cam channel. The location of the cam follower in the cam channel is set by a position of the first trigger. Methods of operating the various embodiments disclosed are also provided.

RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.15/037,963, filed May 19, 2016, which is a national phase application ofInternational Patent Application PCT/US2014/066438, filed Nov. 19, 2014,which claims the benefit of priority to provisional U.S. PatentApplication Ser. No. 61/906,290 filed Nov. 19, 2013. The disclosures ofU.S. patent application Ser. No. 15/037,963, International PatentApplication PCT/US2014/066438, and provisional U.S. Patent ApplicationSer. No. 61/906,290 are hereby incorporated by reference in theirentireties.

FIELD OF THE DISCLOSURE

The present disclosure pertains broadly to the field of fasteners and/orapplicators. More specifically, the disclosure relates to surgicalapplicators of implants and/or fasteners, including but not limited tosterilized fasteners such as staples.

BACKGROUND

Atrial fibrillation is a relatively common condition characterized by avery rapid heartbeat of the left and right atrium. While atrialfibrillation is not normally fatal itself, it has been associated withan increased risk of stroke. It is believed that the rapid heartbeatcauses blood to pool in the left atrial appendage which causes embolithat are released into the left atrium from where they can enter thecerebral vasculature, thus causing a stroke. In addition to stroke, theemboli can enter coronary circulation, potentially causing myocardialinfarction, or can enter peripheral circulation, potentially causingperipheral vascular disease.

The risk of stroke in patients suffering from atrial fibrillation can bereduced in a variety of ways. For example, blood thinning drugs can beused to reduce the risk of clot formation. The use of blood thinners,however, is contraindicated in patients at risk of bleeding disorders.More aggressive treatment protocols have been proposed which involveclosing the left atrial appendage. Closure and excision may be performedin open surgical procedures, typically requiring the patient to beplaced on by-pass and the chest to be opened through the sternum.Alternatively, thoracoscopic and other less invasive procedures havebeen proposed. U.S. Pat. No. 5,306,234 teaches the performance ofbeating heart procedures using otherwise conventional surgicaltechniques. The use of conventional techniques through small chestpenetrations while the heart is beating can be difficult to perform.U.S. Pat. No. 5,865,791 describes an intravascular approach where toolsare introduced through the vasculature and passed into the left atrium.The tools are used to ablate or fuse the left atrial appendage from theinside using energy, adhesives, or the like. The '791 patent alsodescribes a thoracoscopic procedure where a tether is placed over theneck of the atrial appendage and tied off to achieve isolation. The '791patent still further suggests other closure elements including sutures,staples, shape-memory wires, biocompatible adhesives, and the like. U.S.Pat. No. 6,488,689 describes a transpericardial procedure where thedistal tip of the left atrial appendage is grasped and pulled backwardlythrough a capture loop which encircles the base of the left atrialappendage.

A compliant closure structure for the sealing bodily structures such asthe left atrial appendage is described in co-pending, commonly ownedU.S. Patent Publication 2007/0260278 (application Ser. No. 11/744,135),the full disclosure of which is incorporated herein by reference in itsentirety. The compliant structure described in the '278 publicationcomprises an elastomeric body having a pair of opposed legs which may bearranged in an oval or a U-shaped configuration to define an openingtherebetween. By placing the opening between the legs over the leftatrial appendage and aligning it with the base of the appendage, thestructure may be closed to provide the desired sealing. To hold thestructure closed, a number of discrete, axially spaced-apart tissuepenetrating fasteners are arranged along the lengths of each of thelegs. By compressing the legs together to press-fit the closure devices,the compliant structure may be closed to provide a compliant seal whicheffectively isolates the left atrial appendage.

The '278 publication describes a particular delivery tool for thecompliant closure structure. The delivery tool includes jaws which canbe inserted into the legs of the closure structure and actuated to closethe jaws in the legs over the left atrial appendage. The jaws furtherinclude comb studs which engage and press fit the closure devices inorder to hold the compliant structure in its closed, sealingconfiguration. The studs are intended to be retracted to allow thedelivery tool to be removed.

Although functional, the delivery tool of the '278 publication hascertain shortcomings. For example, the actuation of the jaws andretraction of the comb studs can be performed out of order, increasingthe risk that the delivery of the compliant structure will fail.Moreover, positioning and orientation of the delivery tool can bedifficult, particularly when the tool is introduced through anintercostal penetration to access the left atrium. Additionally, thejaws in the device of the '278 publication are attached in the axialplane of the device shaft. Such a straight line of attachment can makeit more difficult to align the jaws with the base of the appendage andacross the os (i.e., ostium) of the atrium leading into the appendage.If the closure device is not aligned across the base to completely closethe os, gaps or openings (referred to as “cul-de-sacs”) can remain atthe site of closure, increasing the risk of thrombus formation in theatrium. The importance of forming a complete seal of the os which isfree from such cul-de-sacs is discussed in Salzberg et al. (2008) Eur.J. Cardiothoracic Surg. 34:766-770.

For these reasons, it would be desirable to provide improved deliverytools for use with the tissue closure devices described in U.S. PatentPublication 2007/0260278. It would be further desirable if the deliverytools and methods of their use were compatible with the delivery ofother tissue closure devices and for procedures in addition to closureof the left atrial appendage.

SUMMARY

A surgical applicator for a fastener according to an example embodimentcomprises a handle, a first trigger coupled movably with respect to thehandle, and a second trigger coupled movably with respect to the firsttrigger, but operatively arranged to move in tandem with the firsttrigger during movement of the first trigger. An interlock is coupled tothe second trigger and operatively arranged to selectively preventmovement of the second trigger relative to the first trigger dependingon a position of the first trigger with respect to the handle.

According to an example embodiment, the interlock permits movement ofthe second trigger relative to the first trigger when the first triggeris moved from a first position to a second position, and restrictsmovement of the second trigger relative to the first trigger when thefirst trigger is not in the second position.

According to an example embodiment, a second interlock is coupled to thefirst trigger and operatively arranged to selectively prevent movementof the first trigger relative to the handle depending on a position ofsecond trigger.

According to an example embodiment, a jaw assembly is selectively openedand closed via movement of the first trigger.

According to an example embodiment, movement of the second triggerselectively retracts one or more fastener supporting structures of thejaw assembly with respect to at least one jaw of the jaw assembly.

According to an example embodiment, the interlock includes a camfollower engaged with a cam channel.

According to an example embodiment, the handle includes the cam channeland the second trigger includes the cam follower.

According to an example embodiment, the cam channel has a first leg thatpermits tandem movement of the second trigger with the first triggerduring closing of the first trigger and a shoulder that preventsmovement of the second trigger relative to the first trigger until thefirst trigger is closed.

According to an example embodiment, the cam channel has a second legthat permits tandem movement of the second trigger with the firsttrigger during re-opening of the first trigger after the second triggerhas been closed relative to the first trigger.

According to an example embodiment, the cam channel includes at leastone leg formed concentrically with respect to a first pivot about whichthe first trigger is rotatably coupled to the handle and a transverseportion formed concentrically with respect to a second pivot about whichthe second trigger is rotatably coupled to the first trigger.

According to an example embodiment, the at least one leg includes twolegs, and the transverse portion is connected between the two legs.

A fastener applicator according to an example embodiment comprises ahandle, a first trigger coupled rotatably with respect to the handle,and a second trigger coupled rotatably with respect to the handle. Aninterlock is disposed with the second trigger and comprises a camfollower engaged in a cam channel that selectively prevents rotation ofthe second trigger relative to the first trigger depending on a locationof the cam follower within the cam channel. The location of the camfollower in the cam channel is set by a position of the first trigger.

According to an example embodiment, the handle includes the cam channeland the second trigger includes the cam follower.

According to an example embodiment, the cam channel has a first leg thatpermits tandem movement of the second trigger with the first triggerduring closing of the first trigger and a shoulder that preventsmovement of the second trigger relative to the first trigger until thefirst trigger is closed.

According to an example embodiment, the cam channel has a second legthat permits tandem movement of the second trigger with the firsttrigger during re-opening of the first trigger after the second triggerhas been closed relative to the first trigger.

A fastener applicator according to an example embodiment comprises ahandle, a shaft extending distally from the handle and a jaw assembly ata distal end of the shaft having one or more fastener supportingstructures. A first trigger is coupled movably with respect to thehandle and to the jaw assembly such that movement of the first triggerrelative to the handle selectively closes the jaw assembly. A secondtrigger is coupled movably with respect to the first trigger, the secondtrigger coupled to the jaw assembly such that movement of the secondtrigger relative to the first trigger selectively retracts the one ormore fastener supporting structures; and an interlock coupled to thesecond trigger and operatively arranged to selectively prevent movementof the second trigger relative to the first trigger depending on aposition of the first trigger.

According to an example embodiment, the interlock permits movement ofthe second trigger relative to the first trigger when the first triggeris closed and prevents movement of the second trigger relative to thefirst trigger when the first trigger is open.

According to an example embodiment, a second interlock is coupled to thefirst trigger and operatively arranged to selectively prevent movementof the first trigger relative to the handle depending on a position ofsecond trigger.

According to an example embodiment, the interlock includes a camfollower engaged with a cam channel.

According to an example embodiment, the handle includes the cam channeland the second trigger includes the cam follower.

According to an example embodiment, the second trigger is movable intandem with the first trigger during movement of the first trigger.

A fastener applicator according to an example embodiment comprises ahandle, a first trigger movable with respect to the handle between afirst position and a second position, and a second trigger movable withrespect to the first trigger between an initial position and an actuatedposition. A first interlock is coupled to the second trigger andoperatively arranged to selectively prevent movement of the secondtrigger relative to the first trigger until the first trigger is movedinto the second position. A second interlock is coupled to the firsttrigger and operatively arranged to selectively prevent movement of thefirst trigger relative to the handle until the second trigger is movedinto the actuated position.

According to an example embodiment, a pair of jaws is included, with thefirst trigger coupled to the pair of jaws for setting the pair of jawsin an open configuration when the first trigger is in the first positionand in a closed configuration when the first trigger is in the secondposition.

According to an example embodiment, one or more fastener supportingstructures are disposed with the pair of jaws. The second trigger iscoupled to the one or more fastener supporting structures for settingthe one or more fastener supporting structures in a deployedconfiguration when the second trigger is in the initial position and ina retracted configuration when the second trigger is in the actuatedposition.

A method of operating a fastener applicator according to an exampleembodiment comprises: (i) repositioning a first trigger of the fastenerapplicator with respect to a handle from a first position to a secondposition, (ii) moving a second trigger in tandem with the first trigger,(iii) preventing repositioning of a second trigger between an initialposition and an actuated position relative to the first trigger with aninterlock coupled to the second trigger until the first trigger is movedto the second position, and (iv) repositioning the second trigger to theactuated position relative to the first trigger after the first triggeris moved to the second position.

A method of operating a fastener applicator according to an exampleembodiment comprises: (i) moving a first trigger of the fastenerapplicator with respect to a handle from a first position to a secondposition, (ii) preventing movement of a second trigger between aninitial position and an actuated position relative to the first triggerwith an interlock coupled to the second trigger until the first triggeris moved to the second position, (iii) rearranging a cam follower and acam channel of the interlock with respect to each other due to themoving of the first trigger to the second position, and (iv) moving thesecond trigger to the actuated position relative to the first triggerafter the first trigger is moved to the second position.

A method of operating a fastener applicator according to an exampleembodiment comprises: (i) moving a first trigger of the fastenerapplicator with respect to a handle from a first position to a secondposition, (ii) preventing movement of a second trigger between aninitial position and an actuated position relative to the first triggerwith a first interlock coupled to the second trigger until the firsttrigger is moved to the second position, (iii) moving the second triggerto the actuated position relative to the first trigger after the firsttrigger is moved to the second position, (iv) preventing movement of thefirst trigger relative to the handle back to the first position with asecond interlock coupled to the first trigger until the second triggeris moved to the actuated position, and (v) moving the first trigger backto the first position relative to the handle after the second trigger ismoved to the actuated position.

A method of operating a fastener applicator according to an exampleembodiment comprises: (i) repositioning a first trigger of the fastenerapplicator with respect to a handle from a first position to a secondposition, (ii) closing a jaw assembly coupled to the handle of thefastener applicator due to movement of the first trigger to the secondposition, (iii) preventing repositioning of a second trigger between aninitial position and an actuated position relative to the first triggerwith an interlock coupled to the second trigger until the first triggeris moved to the second position, (iv) repositioning the second triggerto the actuated position relative to the first trigger after the firsttrigger is moved to the second position, and (v) retracting one or morefastener supporting structures comprising at least one protrusionmovably extendable and retractable with respect to at least one jaw ofthe jaw assembly of the fastener applicator due to repositioning of thesecond trigger to the actuated position.

According to an example embodiment, the fastener applicator comprises asecond interlock coupled to the first trigger and the method furthercomprises preventing movement of the first trigger from the secondposition to the first position with the second interlock until thesecond trigger is moved to the actuated position relative to the firsttrigger, and repositioning the first trigger from the second positionback to the first position after the second trigger is moved to theactuated position relative to the first trigger.

According to an example embodiment, the interlock includes a camfollower engaged with a cam channel.

According to an example embodiment, rotating the first trigger from thefirst position to the second position includes traversing the camfollower along a first leg of the channel.

According to an example embodiment, the first leg is formedconcentrically with respect to a pivot about which the first triggerrotates.

According to an example embodiment, rotating the second trigger to theactuated position relative to the first trigger includes traversing thecam follower along a portion of the channel transverse to the first leg.

According to an example embodiment, the handle includes the cam channeland the second trigger includes the cam follower.

According to an example embodiment, rotating the first trigger from thefirst position to the second position including moving the secondtrigger in tandem with the first trigger.

BRIEF DESCRIPTION OF THE DRAWINGS

The following descriptions should not be considered limiting in any way.With reference to the accompanying drawings, like elements are numberedalike:

FIG. 1 is a perspective view of a closure device applicator constructedin accordance with to an example embodiment of the present disclosure;

FIG. 2 is a partial cross-sectional elevation view of the closure deviceapplicator of FIG. 1 , shown with the jaws open and rotated 90° relativeto the position shown in FIG. 1 ;

FIG. 3 is a partial, cross-sectional elevation view of the deviceapplicator similar to FIG. 2 , shown with the first trigger closedrelative to the handle in order to close the jaws, and the secondtrigger open (or spaced apart) with respect to the first trigger;

FIG. 4 is a partial, cross-sectional elevation view of the closuredevice applicator similar to that shown in FIGS. 2 and 3 with the secondtrigger closed relative to the first trigger demonstrating a retractionof the closure device-engaging studs;

FIG. 5 is a partial, cross-sectional elevation view of the closuredevice applicator of FIGS. 2-4 , shown with the first trigger re-openedwith respect to the handle in order to open the jaws while the closuredevice-engaging studs remain retracted;

FIG. 6A-6D illustrate the movement of the jaw and stud engagement withthe closure devices of a tissue closure device according to an exampleembodiment of the present disclosure;

FIG. 7 illustrates an exemplary mechanism by which the closuredevice-engaging studs are retracted within the jaws according to anexample embodiment of the present disclosure;

FIG. 8 illustrates an interlock formed between a cam channel, slot, orgroove in a handle of the applicator of FIG. 1 , shown in cross-section,and a cam follower projecting from a second trigger of the applicator ofFIG. 1 , shown in a perspective and exploded view orientation accordingto an embodiment of the present disclosure;

FIGS. 9A-9E illustrate various positions of the cam follower of FIG. 8along the cam channel of the interlock as first and second triggers ofthe applicator are moved through the configurations depicted in FIGS.2-5 ;

FIG. 10 illustrates operation of the interlock of FIG. 8 with respect tothe first and second triggers of the applicator of FIG. 1 ; and

FIG. 11 illustrates use of the applicator according to an exampleembodiment of the present disclosure, wherein the applicator is used forclosing a closure device over a left atrial appendage.

DETAILED DESCRIPTION

A detailed description of one or more embodiments of the disclosedapparatus and method are presented herein by way of exemplification andnot limitation with reference to the Figures.

Embodiments of the present disclosure provide alternative and improvedapparatuses, systems, and methods for deploying one or more closuredevices or fasteners to tissue. An exemplary tissue structure of apatient at risk of stroke or other adverse events resulting from embolireleased into circulation from the left atrial appendage, may includethe left atrial appendage. Patients benefiting from the exemplaryprocedures disclosed herein will at least partially include thosesuffering from atrial fibrillation which can cause clot and thrombusformation in the left atrial appendage, thus increasing the chance ofemboli release.

Exemplary embodiments of the present disclosure provide a mechanicalclosure device applicator for introducing the fastener over the tissuestructure, which fastener is left in place in order to close and/or sealthe tissue structure. A portion of the tissue structure extending beyondthe fastener may then be cut, excised, or otherwise removed, althoughthis may be left to the physician's preference. In one embodiment, thetissue fastener comprises a compression body having at least twoopposed, compliant tissue-engaging surfaces which are placed overopposite sides of the tissue structure. In this embodiment, thetissue-engaging surfaces are held together by a plurality of axiallyspaced-apart tissue-penetrating fasteners, which extend from one of thesurfaces, through the intermediate tissue, and into the other surface toboth hold the compression body in place and to apply a desired level ofcompression force, which is determined by both the softness of thecompression body and the distance between the surfaces when they arefully attached. A well may be provided in the compression body aroundthe tissue-penetrating barb of the fastener such that a gasket seal isformed by the compression body around the puncture site in the tissue. Astabilizing lip may be provided in one leg of the compression body toprevent a rolling motion of one leg with respect to another leg of thecompression body in order to keep the two opposing soft members linearlyaligned. More detailed descriptions of fasteners suitable for use withembodiments of the present disclosure are found in patent publicationU.S. 2007/0260278, the full disclosure of which has been previouslyincorporated herein by reference.

Referring now to FIG. 1 , a fastener applicator 10 constructed inaccordance with various embodiments of the present disclosure comprisesa shaft 12 having a handle assembly 14 at its proximal end, and a jawassembly 16 at a distal end, where individual jaws 18 and 20 are adaptedto carry a fastener 22, as best illustrated in FIGS. 6A-6D. The fastener22 is shown in an example embodiment to have a IJ-shaped configurationwhich defines a V-shaped region 24 for receiving the left atrialappendage or other tissue structure when the jaws are open as shown inFIGS. 1, 2 , and 6A. A plurality of studs 26 are formed along the innersurfaces of each jaw 20 and 18 to engage tissue-penetrating fastenerswhich comprise penetrating components 28 and receptacle components 30,as best shown in FIG. 6A. The handle assembly 14 will include a handle32, a first trigger 34, and a second trigger 36.

Referring now to FIGS. 2 and 6A, the fastener applicator 10 is shown inits shelf or delivery configuration with the fastener 22 received overthe jaw assembly 16 and the V-shaped opening 24 in the device ready tobe placed over a tissue structure such as the left atrial appendage (seeFIG. 10 ). The triggers 34 and 36 are each respectively movable betweenan initial or first position and an actuated or second position. As willbe discussed in more detail below, the first trigger 34 is movablebetween its respective positions relative to the handle 32, while thesecond trigger 36 is movable between its respective positions relativeto the first trigger 34. In one embodiment, in their respective firstpositions, the first trigger 34 and the second trigger 36 are initiallyin a fully open position, that is, pivoted fully away from the handle32. For this reason, it is to be understood that any mention of“opening” the first trigger 34 refers more generally to moving the firsttrigger 34 toward its first or initial position, while any mention of“closing” the first trigger 34 or the second trigger 36 refers moregenerally to moving the first trigger 34 or the second trigger 36towards its respective second or actuated position.

After the fastener 22 is advanced over the left atrial appendage orother target tissue structure, the jaws 18 and 20 are closed by manuallypulling the first trigger 34 toward the handle 32, as shown in FIGS. 3and 6B. The first trigger 34 is mounted on a pin or pivot 40, which isshown to be fixedly secured to the handle assembly 14, thereby rotatablycoupling the first trigger 34 to the handle 32. Closing the firsttrigger 34 with respect to the handle 32, that is, pivoting about thepivot 40 from the first position of the first trigger 34 to the secondposition, proximally retracts the rod 42 which is linked to the firsttrigger 34 by a pin or pivot 41 and a lever 43. The rod 42 is attachedto a pin 44 (FIG. 6B) which is pivotally attached to the proximal endsof the jaws 18 and 20 and proximally retracts the jaws so that they areclosed by the movement of slots 46 over pins 48 in an end frame 50attached to a stationary sleeve 52. When the jaws 18 and 20 are closed,the studs 26 engage the tissue penetrating components 28 and the tissuepenetrating receptacles 30 so that they engage and lock with each other,thus closing the two legs of the fastener 22, as shown in FIG. 6B.

The second trigger 36 may be mounted on the pin 41 so that the secondtrigger 36 moves, actuates, or closes with respect to the handle 32 intandem with the first trigger 34. In this way, the second trigger 36 isrotatably coupled to the handle 32, although indirectly via the pin 41and the first trigger 34. By “in tandem” it is meant that movement ofthe first trigger 34 translates at least partially into correspondingmovement of all or portions of the second trigger 36. In the illustratedembodiment, movement of the first trigger 34 causes a substantiallyequivalent amount of rotational movement of the second trigger 36,although there could be gears, linkages, springs, or the like to cause alesser or greater degree of movement of the second trigger 36 to resultfrom corresponding movement of the first trigger 34.

The applicator 10 may optionally include an interlock 60 in someembodiments. According to the illustrated embodiment, as the firsttrigger 34 and the second trigger 36 are moved in tandem, a ratchetingtooth surface 62 of the interlock 60 is closed against pins 64, as shownin FIG. 3 , so that the first trigger 34 cannot be re-opened once thejaw assembly 16 has been closed, either completely or to a certaindegree of closure or spacing between the jaws. This is advantageous asdescribed above, since the jaws should not be completely opened prior toretracting the studs 26 by closing the second trigger 36, as will bedescribed below. The ratcheting tooth surface 62 can include any numberof ratchets or notches such that the first trigger 34 can beprogressively closed (i.e., brought into approximation of the handle 32)by more fully driving the ratcheting tooth surface 62 along the pins 64in the direction of closure for the first trigger 34 (e.g., from theconfiguration of FIG. 2 to the configuration of FIG. 3 ).

Additionally, as the first trigger 34 is moved to its actuated, closed,or second position (i.e., moved or actuated to the configuration of FIG.3 ) in order to close the jaws 18 and 20 of the jaw assembly 16, acorner 66 (see FIG. 2 ) of the interlock 60 will engage an inclinedsurface 68 on a clicker pin 70 to disengage the clicker pin 70 from aholding pin 72, thus allowing a spring 74 to push the pin 70 downward sothat a bottom surface 76 thereof strikes the bottom of the handle 32,thus causing a loud click to audibly alert the physician that the jawshave been closed and the interlock 60 has been engaged. This audibleconfirmation indicates to the physician or other medical personnel thatthe fastener 22 has been closed and that the studs 26 can be retracted.

The studs 26 are initially in an extended configuration, as shown inFIGS. 2-3 and 6A-6B, and then retracted by closing second trigger 36against the first trigger 34, as shown in FIGS. 4 and 6C. Closure of thesecond trigger 36 relative to the first trigger 34 draws the outersleeve 54 proximally over the stationary sleeve 52 which draws pullwires 80 proximally to pull stud combs 84 or other fastener supportingstructures, proximally, as shown in FIG. 7 . The stud combs 84 aremounted on pins 86 which travel in slots 88 formed in each of the jaws18 and 20. The second trigger 36 is pivotally mounted on, or rotatablycoupled to, the first trigger 34 by the pin 41 and is coupled to thestationary sleeve by pins 90 and 91 and a lever 92. It is to beappreciated that the studs 26 can take other shapes or arrangementsand/or that other fastener supporting structures (i.e., structurescapable of supporting the fasteners 22 during closing and engagingthereof) can be included in lieu of the studs 26 that are eitherdisengaged from or engaged to the fastener 22 upon intentional closureor movement of the second trigger 36. For example, in lieu of aplurality of individual studs 26, a supporting structure in the form ofa single unitary rail supporting all of the components 28 can beincluded in one embodiment.

Movement of the second trigger 36 relative to the first trigger 34,e.g., closure of the second trigger 36, disengages the interlock 60 byengaging a ramped surface 94 attached to the interlock 60 against afixed pin 96 in the second trigger 36. In this way, the interlock 60selectively permits or prevents movement, e.g., opening, of the firsttrigger 34 depending on a position of the second trigger 36. In otherwords, movement of the second trigger 36 to its corresponding secondposition, relative to the first trigger 34, releases the interlock 60.The pin 96 follows the path shown in broken line in FIG. 3 to engage thesurface 94. The ramped surface 94 is caused to move downwardly, pullingthe ratchet teeth 62 away from the fixed pins 64, as shown in FIGS. 4and 5 . The triggers 34 and 36 are now ready to be opened in order toopen the jaws, as will now be described.

Referring now to FIGS. 5 and 7C, the jaws 18 and 20 may be opened byreleasing manual compression on the first and second triggers 34 and 36,allowing spring 98 which was compressed during closure of the firsttrigger 34 to push rod 42 (attached to pivot 44) distally forward,opening the jaws and leaving the fastener 22 in place.

FIG. 8 shows a cross-section of the handle 32 as well as the secondtrigger 36 exploded therefrom. An interlock 100 is included between thehandle 32 and the second trigger 36 to selectively permit and preventrotational movement of the second trigger 36 with respect to the firsttrigger 34. The first trigger 34 does not form a part of the interlock100 in the illustrated embodiment, and therefore is not illustrated inFIG. 8 . However, it is to be understood that the first trigger 34 inthe embodiment of FIG. 8 would be nevertheless be secured to the secondtrigger 36 at the pivot 41 as described herein with respect to the otherFigures. Additionally, the shaft 12 and the jaw assembly 16 are notillustrated in some Figures, including FIG. 8 , but can be included asdescribed herein with respect to the other Figures.

More specifically, the interlock 100 includes a cam follower 102 and achannel 104. In the illustrated embodiment, the cam follower 102 isformed as a protrusion or projection extending from or otherwise coupledto the second trigger 36, and is preferably round in cross section butalternatively may be of other shapes. The cam follower 102 can beintegrally formed with the second trigger 36 or affixed thereto as aseparate component. The channel 104 may be formed as a groove,depression, notch, slot, or the like in the handle 32. The follower 102is configured to engage with and/or travel along the channel 104 (andthus will be restricted to movement within the channel 104) when thesecond trigger 36 is assembled with the handle 32. It is noted that theapplicator 10 can include other exemplary embodiments of a singlefollower 102 and a single channel 104 if desired, but for symmetry,balance, etc., the second trigger 36 may include two cam followers 102(e.g., another follower 102 hidden from view in FIG. 8 on the oppositelateral side of the second trigger 36 and mirroring the illustrated oneof the followers 102 about a plane bisecting the second trigger 36), andthe handle 32 may correspondingly include two cam grooves 104 (e.g.,another channel 104 located in the half of the handle 32 not shown inFIG. 8 , which mirrors the illustrated channel 104 about the plane usedto form the cross-sectional view of the handle 32 in FIG. 8 ).

The mechanical coupling of the follower 102 to the second trigger 36prevents rotation of the second trigger 36 relative to the first trigger34 when the follower 102 abuts against the walls or shoulders definingthe channel 104. For example, FIGS. 9A-9E show various positions of thefollower 102 (without the second trigger 36 for clarity) correspondingto the various combinations of positions of the first and secondtriggers 34 and 36 of the applicator 10. That is, for example, theposition of the follower 102 in FIG. 9A corresponds to an initial,shelf, or delivery configuration of the applicator 10 shown in FIG. 2 ,i.e., before the triggers 34 or 36 have been actuated.

In the position of FIG. 9A, rotation of the second trigger 36 isprevented by interference of the follower 102 with a shoulder 106 of thechannel 104. That is, movement of the second trigger 36 relative to thefirst trigger 34 occurs about the pin 41, which rotationally couples thesecond trigger 36 to the first trigger 34. Thus, rotation of the secondtrigger 36 about the pin 41 (if unblocked) would result in the camfollower 102 following an arc defined by a circular path concentric withthe pin 41, e.g., illustrated as a circle 107 in FIG. 10 . From FIG. 10, it is clear that rotational movement of the cam follower 102 along anarc defined by the circle 107 is not possible due to interferencebetween the cam follower 102 and the shoulder 106. Accordingly, rotationof the second trigger 36 about the pin 41 relative to the first trigger34 is prevented by the interference between the cam follower 102 and theshoulder 106.

The channel 104 is shaped with a leg 108, which permits the secondtrigger 36 to travel in tandem with the first trigger 34 as the firsttrigger 34 is moved toward its second position, i.e., rotated about thepivot 40 toward the configuration of the applicator 10 shown in FIG. 3 .That is, again referring to FIG. 10 , tandem movement of second trigger36 due to movement of the first trigger 34 would result in the camfollower 102 traveling along an arc defined by a circular pathconcentric with the pivot 40, illustrated in FIG. 10 by a circle 109.The first leg 108 is arranged to lie substantially along such an arcformed by the circle 109, thereby enabling the cam follower 102 totravel along the leg 108 during rotation of the first and secondtriggers 34 and 36 about the pin 40.

FIG. 9B illustrates the position of the follower 102 in the channel 104when the first trigger 34 is rotated partially toward the configurationof FIG. 3 , e.g., with ratcheting tooth surface 62 of the interlock 60at most only partially driven along and engaged with the pins 64. At theposition of FIG. 9B, the shoulder 106 continues to prevent rotation ofthe second trigger 36 by blocking movement of the follower 104 in thedirection necessary to rotate the second trigger 36.

FIG. 9C illustrates the position of the follower 102 after the triggerfirst 34 has been moved to the configuration of FIG. 3 and theratcheting tooth surface 62 of the interlock 60 is fully driven alongand engaged with the pins 64. It can be appreciated in view of FIGS. 3and 9C that rotation of the second trigger 36 becomes possible at thisposition because the shoulder 106 no longer abuts the follower 102.Alternatively stated, it is to be appreciated that tandem movement ofthe second trigger 36 with the first trigger 34 has shifted the positionof the cam follower 102 and the pin 41 relative to the channel 104(since the pin 41 and the cam follower 102 are directly coupled to thesecond trigger 36 in the illustrated embodiment). It is to be furtherunderstood that this shifting of the position of the pin 41 and the camfollower 102 has also moved the location of the circle 107 to align witha portion 110 of the channel 104 that is transverse to the leg 108 andarranged along an arc that is concentric with respect to the pin 41.

In view of the foregoing it can be seen that the position of the firsttrigger 34 selectively prevents or permits rotation of the secondtrigger 36. Again, movement of the first trigger 34 causes tandemmovement of the second trigger 36, which results in the follower 102first traversing along the leg 108 of the channel 104. However, movementof the second trigger 36 relative to the first trigger 34 is preventeddue to interference between the cam follower 102 and the shoulder 106.Relative movement of the second trigger 36 with respect to the firsttrigger 34 is thus prevented until the cam follower 102 is moved to aposition at which the cam follower 102 no longer abuts the shoulder 106.FIG. 9D shows the position of the follower 102 after movement of thesecond trigger 36 relative to the first trigger 34 is permitted and thesecond trigger 36 has also been actuated to its second position, therebycorresponding to the configuration of the applicator 10 shown in FIG. 4.

The channel 104 is shaped with another leg 112 that enables the follower102 to continue to traverse the channel 104 such that the second trigger36 can again move in tandem with the first trigger 34 as the firsttrigger 34 is moved to reopen the jaw assembly 16, i.e., as the firsttrigger 34 is moved back toward its first position. It is to beappreciated that the leg 112, similar to the leg 108, is formed along anarc that is concentric to the pivot 40. This accordingly enables the camfollower 102 to travel along the leg 112 as the second trigger 36 movedin tandem with the first trigger 34 as the first trigger 34 is rotatedabout the pivot 40. FIG. 9E accordingly shows the corresponding locationof the follower 102 in the channel 104 when the first trigger 34 isreturned to its first or initial position, which may correspond to theapplicator 10 assuming the configuration of FIG. 5 in which the jawassembly 16 is again opened.

It is to be appreciated that the channel 104 can take other shapes inother embodiments depending on the desired relative movement of thefirst and second triggers 34 and 36 relative to each other and to thehandle 32. More specifically, the channel 104 will include a leg orportion for each optionally desired stage of movement of the firsttrigger 34 and of the second trigger 36, with the legs and/or portionsof the channel 104 being concentric with respect to the pivot aboutwhich rotation is desired for each stage of movement. Thus, in order tosequentially permit (i) tandem movement of both of the first and secondtriggers 34 and 36 about a first pivot (e.g., the pivot 40), then (ii)movement of the second trigger 36 relative to the first trigger 34 abouta second pivot (e.g., the pivot 41), and then (iii) tandem movement ofthe first and second triggers 34 and 36 again with respect to the firstpivot, the channel 104 will include two legs (e.g., the legs 108 and112) that are spaced apart but both concentric with respect to the firstpivot (e.g., the pivot 40), which enables the movements of stages (i)and (iii), and a transverse portion (e.g., the portion 110) connectingbetween the two legs (e.g., the legs 108 and 112) that is formedconcentrically with respect to the second pivot (e.g., the pivot 41) toenable the movement of stage (ii).

From the above description and the FIGS. 9A-9E, it is clear that theinterlock 100 accordingly prevents rotation of the second trigger 36until after the trigger first 34 is first rotated, preferably fullyrotated (i.e., from a first position to a second position). Since fullrotation of the first trigger 34 (e.g., as shown in FIG. 3 ) correspondsto the closing of the jaw assembly 16, the interlock 100 thusadvantageously selectively prevents retraction of the studs 26 (due torotation of the second trigger 36) until after the jaw assembly 16 isclosed. Referring again to the above description, it is again noted thatthe interlock 60 is released depending on the position of the secondtrigger 36 relative to the first trigger 34. Thus, the location of thefirst trigger 34 is first used to release the interlock 100, selectivelypermitting movement of the second trigger 36 relative to the firsttrigger 34, and thereafter the location of the second trigger 36relative to the first trigger 34 is used to release the interlock 60,which selectively permits movement of the first trigger 34 relative tothe handle 32 back toward the initial position for the first trigger. Inthis way, the aforementioned order of the steps of (1) closing the jaws,(2) retracting the studs, and (3) opening the jaws is maintained andensured by use of either or both of the interlocks 60 and 100.

It is to be appreciated that the interlock 100 can take other forms innon-illustrated embodiments. For example, in one embodiment the channel104 is alternatively formed with the second trigger 36 and the follower102 with the handle 32. In another embodiment, part of the channel 104is formed in one of the handle halves while the other is formed in theother of the handle halves.

Referring now to FIG. 11 , one specific example of use is illustrated.In this example, the fastener applicator 10 is used to deliver one ofthe fasteners 22 over the base of a left atrial appendage LAA in an openchest, beating heart procedure. The sternum S is opened, spreading theribs R to provide a working space over the heart. After opening thepericardial sack, the heart may be lifted and turned, for example usinga sheet of gauze or other material which is placed behind the heart, toexpose the left atrial appendage within the opening as shown in FIG. 10. After the left atrial appendage LAA is exposed, the jaws 18 and 20 ofthe fastener applicator are placed around the base of the appendage bymanipulating the shaft 12, as shown in FIG. 10 . The angle of the jaws18 and 20 relative to the shaft, typically about 15°, is highlyadvantageous as it allows the jaws to engage the base of the left atrialappendage so that they are generally parallel with the os between theappendage and the left atrium LA. If the plane of the jaws was alignedwith the shaft, it would be difficult to achieve this orientation andthe risk of closing the appendage and leaving a cul-de-sac (an openspace beyond the os and into interior of the left atrial appendage) isgreatly increased. Such cul-de-sac is problematic as it can be a sourceof clotting and, if created, must be closed in the same or laterprocedure. Once the jaws 18 and 20 properly position the fastener 22about the base of the left atrial appendage, the jaws are actuated andthe fastener deployed as described previously.

While the invention has been described with reference to an exemplaryembodiment or embodiments, it will be understood by those skilled in theart that various changes may be made and equivalents may be substitutedfor elements thereof without departing from the scope of the invention.In addition, many modifications may be made to adapt a particularsituation or material to the teachings of the invention withoutdeparting from the essential scope thereof. Therefore, it is intendedthat the invention not be limited to the particular embodiment disclosedas the best mode contemplated for carrying out this invention, but thatthe invention will include all embodiments falling within the scope ofthe claims. Also, in the drawings and the description, there have beendisclosed exemplary embodiments of the invention and, although specificterms may have been employed, they are unless otherwise stated used in ageneric and descriptive sense only and not for purposes of limitation,the scope of the invention therefore not being so limited. Moreover, theuse of the terms first, second, etc. do not denote any order orimportance, but rather the terms first, second, etc. are used todistinguish one element from another. Furthermore, the use of the termsa, an, etc. do not denote a limitation of quantity, but rather denotethe presence of at least one of the referenced item.

What is claimed is:
 1. A fastener applicator comprising: a handle; afirst trigger coupled rotatably with respect to the handle; a secondtrigger coupled rotatably with respect to the handle; and an interlockdisposed with the second trigger, the interlock comprising a camfollower engaged in a cam channel that selectively prevents rotation ofthe second trigger relative to the first trigger depending on a locationof the cam follower within the cam channel, wherein the location of thecam follower in the cam channel is set by a position of the firsttrigger, wherein the handle includes the cam channel and the secondtrigger includes the cam follower, wherein the cam channel has a firstleg that permits tandem movement of the second trigger with the firsttrigger during closing of the first trigger and a shoulder that preventsmovement of the second trigger relative to the first trigger until thefirst trigger is closed and wherein the cam channel has a second legthat permits tandem movement of the second trigger with the firsttrigger during re-opening of the first trigger after the second triggerhas been closed relative to the first trigger.
 2. A fastener applicatorcomprising: a handle; a shaft extending distally from the handle; a jawassembly at a distal end of the shaft having one or more fastenersupporting structures; a first trigger coupled movably with respect tothe handle, the first trigger coupled to the jaw assembly such thatmovement of the first trigger relative to the handle selectively closesthe jaw assembly; a second trigger coupled movably with respect to thefirst trigger, the second trigger coupled to the jaw assembly such thatmovement of the second trigger relative to the first trigger selectivelyretracts the one or more fastener supporting structures; and aninterlock coupled to the second trigger and operatively arranged toselectively prevent movement of the second trigger relative to the firsttrigger depending on a position of the first trigger, wherein theinterlock includes a cam follower engaged with a cam channel, whereinthe handle includes the cam channel and the second trigger includes thecam follower, wherein the cam channel has a first leg that permitstandem movement of the second trigger with the first trigger duringclosing of the first trigger and a shoulder that prevents movement ofthe second trigger relative to the first trigger until the first triggeris closed and wherein the cam channel has a second leg that permitstandem movement of the second trigger with the first trigger duringre-opening of the first trigger after the second trigger has been closedrelative to the first trigger.
 3. The applicator of claim 2, wherein theinterlock permits movement of the second trigger relative to the firsttrigger when the first trigger is closed and prevents movement of thesecond trigger relative to the first trigger when the first trigger isopen.
 4. The applicator of claim 2 further comprising a second interlockcoupled to the first trigger and operatively arranged to selectivelyprevent movement of the first trigger relative to the handle dependingon a position of second trigger.
 5. A fastener applicator comprising: ahandle; a first trigger movable with respect to the handle between afirst position and a second position; a second trigger movable withrespect to the first trigger between an initial position and an actuatedposition; a first interlock coupled to the second trigger andoperatively arranged to selectively prevent movement of the secondtrigger relative to the first trigger until the first trigger is movedinto the second position, wherein the first interlock includes a camfollower engaged with a cam channel, wherein the handle includes the camchannel and the second trigger includes the cam follower, wherein thecam channel has a first leg that permits tandem movement of the secondtrigger with the first trigger during closing of the first trigger and ashoulder that prevents movement of the second trigger relative to thefirst trigger until the first trigger is closed and wherein the camchannel has a second leg that permits tandem movement of the secondtrigger with the first trigger during re-opening of the first triggerafter the second trigger has been closed relative to the first trigger;and a second interlock coupled to the first trigger and operativelyarranged to selectively prevent movement of the first trigger relativeto the handle until the second trigger is moved into the actuatedposition.
 6. The fastener applicator of claim 5 further comprising apair of jaws, the first trigger coupled to the pair of jaws for settingthe pair of jaws in an open configuration when the first trigger is inthe first position and in a closed configuration when the first triggeris in the second position.
 7. The fastener applicator of claim 6 furthercomprising one or more fastener supporting structures disposed with thepair of jaws, the second trigger coupled to the one or more fastenersupporting structures for setting the one or more fastener supportingstructures in a deployed configuration when the second trigger is in theinitial position and in a retracted configuration when the secondtrigger is in the actuated position.